Now showing items 1-20 of 483

    • Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study

      Herbert, Carly; Broach, John; Heetderks, William; Qashu, Felicia; Gibson, Laura; Pretz, Caitlin; Woods, Kelsey; Kheterpal, Vik; Suvarna, Thejas; Nowak, Christopher; et al. (2022-10-18)
      Background: The ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals' use of rapid antigen tests at home and how to facilitate the user experience. Objective: This study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation. Methods: A total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team's interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups. Results: Of the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor's degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants' interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P<.001). Participants reported high satisfaction with self-testing and the smartphone app, with 98.7% (157/159) reporting that they would recommend the self-test and smartphone app to others. These results were consistent across age, race/ethnicity, and gender. Conclusions: Participants' high adherence to the recommended testing schedule, significant reliability between participants and study staff's test interpretation, and the acceptability of the smartphone app and self-test indicate that self-tests for SARS-CoV-2 with a smartphone app for assistance and reporting is a highly feasible testing modality among a diverse population of adults in the United States.
    • The Buddy System: An Intervention to Reduce Distress and Compassion Fatigue and Promote Resilience on a Palliative Care Team During the COVID-19 Pandemic

      McCool, Nancy; Reidy, Jennifer; Steadman, Shawna; Nagpal, Vandana (2022-09-21)
      The SARS-CoV-2 pandemic (COVID-19) dramatically increased the number of stressors on healthcare workers, including palliative care practitioners. Restrictions and increased demands on time made it difficult for the UMass Memorial Health palliative care team to utilize preexisting wellness strategies. In response to team members' stress reactions, a buddy system intervention was conceived and implemented to restore a sense of connection and self-efficacy (Phase 1). Our objective with this quality improvement project was to assess the feasibility and effectiveness of the buddy system and evaluate staff attitudes toward this intervention. After four months, feedback from team members informed redesign to a more structured buddy system (Phase 2). A mixed-methods design of this project included a qualitative online survey along with quantitative data collection with the Professional Quality of Life Scale V (ProQOL V) and the Brief Resilience Scale (BRS) during Phase 1. Phase 2 was also evaluated quantitatively with ProQOL V and BRS. Semi-structured interviews were conducted at the end of this project to enhance qualitative data on staff attitudes and beliefs. Of the 12 study participants, 10 completed all phases of the study. Participants reported the buddy system was a useful, easy-to-implement intervention for mitigating personal distress and compassion fatigue (CF) by providing a strong sense of support and connection to team members.
    • A novel household-based patient outreach pilot program to boost late-season influenza vaccination rates during the COVID-19 pandemic

      Fisher, Lloyd; Loiacono, Matthew M; Payne, Nick; Kelley, Tina; Greenberg, Michael; Charpentier, Mary; LeBlanc, Candace; Sundaresan, Devi; Bancroft, Tim; Steffens, Andrea; et al. (2022-09-13)
      Background: The objective of this study was to test a novel household-based approach to improve late-season influenza vaccine uptake during the 2020-2021 season, using Epic's MyChart patient portal messages and/or interactive voice response telephone calls. Methods: This study was a non-blinded, quality improvement program using a block randomized design conducted among patients from Reliant Medical Group clinics residing in a traditional household (≥2 individuals clinically active in the Reliant system living at the same address). Households were randomized 1:1:1 into intervention arms: non-tailored communication (messaging based on CDC's seasonal influenza vaccination campaign), tailored communication (comprehensive communication including reinforcement of the importance of influenza vaccination for high-risk individuals), and standard-of-care control. Influenza vaccination during the program was captured via medical records, and the odds of vaccination among communication arms versus the control arm were assessed. A survey assessing influenza vaccination drivers was administered using MyChart. Results: Influenza vaccination increased by 3.3% during the program period, and no significant differences in vaccination were observed in intervention arms relative to the control arm. Study operationalization faced substantial challenges related to the concurrent COVID-19 pandemic. Compared with vaccinated survey respondents, unvaccinated respondents less frequently reported receiving a recommendation for influenza vaccination from their healthcare provider (15.8% vs. 42.3%, p < 0.001) or awareness that vaccination could protect themselves and higher risk contacts (82.3% vs. 92.6%, p < 0.001). Conclusions: No significant effects of the interventions were observed. Survey results highlighted the importance of healthcare provider recommendations and the need for increased education around the benefits of vaccination.
    • Mucosal nanobody IgA as inhalable and affordable prophylactic and therapeutic treatment against SARS-CoV-2 and emerging variants

      Li, Qi; Humphries, Fiachra; Girardin, Roxie C; Wallace, Aaron; Ejemel, Monir; Amcheslavsky, Alla; McMahon, Conor T; Schiller, Zachary A; Ma, Zepei; Cruz, John; et al. (2022-09-12)
      Anti-COVID antibody therapeutics have been developed but not widely used due to their high cost and escape of neutralization from the emerging variants. Here, we describe the development of VHH-IgA1.1, a nanobody IgA fusion molecule as an inhalable, affordable and less invasive prophylactic and therapeutic treatment against SARS-CoV-2 Omicron variants. VHH-IgA1.1 recognizes a conserved epitope of SARS-CoV-2 spike protein Receptor Binding Domain (RBD) and potently neutralizes major global SARS-CoV-2 variants of concern (VOC) including the Omicron variant and its sub lineages BA.1.1, BA.2 and BA.2.12.1. VHH-IgA1.1 is also much more potent against Omicron variants as compared to an IgG Fc fusion construct, demonstrating the importance of IgA mediated mucosal protection for Omicron infection. Intranasal administration of VHH-IgA1.1 prior to or after challenge conferred significant protection from severe respiratory disease in K18-ACE2 transgenic mice infected with SARS-CoV-2 VOC. More importantly, for cost-effective production, VHH-IgA1.1 produced in Pichia pastoris had comparable potency to mammalian produced antibodies. Our study demonstrates that intranasal administration of affordably produced VHH-IgA fusion protein provides effective mucosal immunity against infection of SARS-CoV-2 including emerging variants.
    • Impact of COVID-19 on clinical outcomes of robotic retromuscular ventral hernia repair

      Kudsi, Omar Yusef; Kaoukabani, Georges; Bou-Ayash, Naseem; Crawford, Allison S; Gokcal, Fahri (2022-09-09)
      Background: The COVID-19 pandemic disrupted the healthcare sector and forced hospitals to limit the number of elective procedures with the goal of reducing overcrowding of wards and thus viral transmission. Recent trends for ventral hernia repair have shifted towards retromuscular techniques, which normally require a longer length of stay. Therefore, the aim of this study is to investigate the impact of the COVID-19 pandemic on clinical outcomes of robotic retromuscular ventral hernia repair (rRVHR). Methods: Patients who underwent rRVHR up to 600 days before and after March 10, 2020, were included in this retrospective study and assigned to the pre- or post-COVID group depending on the date of their procedure. Pre-, intra-, and postoperative variables including patients' demographics, hernia characteristics, complications, and hernia recurrence were compared between both groups. Results: 153 (46% female) and 141 (51% female) patients were assigned to the pre- and post-COVID groups respectively. Median age was statistically different between both groups [pre-COVID: 57 (48-68) vs. post-COVID 55 (42-64) years, p = 0.045]. Median hospital length of stay (LOS) was 0 day (0-1) in both groups, and same day discharge were 61% pre-pandemic and 70% post-pandemic (p = 0.09). Mean postoperative follow-up was 39.2 (4.1-93.6) months. In total, 26 pre-COVID patients had postoperative complications, out of which 7 were pulmonary complications, whereas 23 complications were recorded in the post-COVID group, with only 3 pulmonary complications (p = 0.88). Rate of surgical-site events was comparable between both groups, and no recurrences were recorded. Conclusion: This is the first study to describe the impact of the COVID-19 on rRVHR. Hospital LOS was comparable between both groups. Rates of medical and hernia specific complications were not altered by the pandemic.
    • Favipiravir in patients with early mild-to-moderate COVID-19: a randomized controlled trial

      Golan, Yoav; Campos, Jesus Abraham Simon; Woolson, Rob; Cilla, Donald; Hanabergh, Rodolfo; Gonzales-Rojas, Yaneicy; Lopez, Reynaldo; Finberg, Robert; Balboni, Armand (2022-09-06)
      Background: Despite vaccination, many remain vulnerable to COVID-19 and its complications. Oral antivirals to prevent COVID-19 progression are vital. Based upon perceived potency and clinical efficacy, favipiravir is widely used to treat COVID-19. Evidence from large randomized controlled trials (RCT) is lacking. Methods: In this multicenter double-blinded placebo-controlled RCT, adults with early mild-to-moderate COVID-19 were 1:1 randomized to favipiravir or placebo. The study evaluated time to sustained clinical recovery (TT-SCR), COVID-19 progression, and cessation of viral shedding. Results: Of 1187 analyzed patients across 40 centers, 83.3% were Hispanic, 89.0% unvaccinated, 70.3% SARS-CoV-2 seronegative, and 77.8% had risk factors for COVID-19 progression. The median time from symptom presentation and from positive test to randomization was three and two days, respectively. There was no difference in TT-SCR (median of 7 days for both groups; p = 0.80), COVID-19 progression [11 patients each (1.9% vs. 1.8%); p = 0.96], time to undetectable virus [median = 6 days, 95% CI (6-8) vs. 7 days, 95% CI (6-9)], or in undetectable virus by end of therapy (73.4% vs. 72.3%; p = 0.94). Outcomes were consistent across the analyzed sub-groups. Adverse events were observed in 13.8% and 14.8% of favipiravir-treated and placebo-treated subjects, respectively. Uric acid elevation was more frequent among favipiravir-treated subjects (19.9% vs. 2.8%). Conclusions: Favipiravir was well tolerated but lacked efficacy in TT-SCR, progression to severe COVID-19, or cessation of viral shedding and should not be used to treat patients with COVID-19.
    • Coronavirus disease 2019 and mechanical circulatory support devices: A comprehensive review

      John, Kevin; Mishra, Ajay Kumar; Nayar, Jemimah; Mehawej, Jordy; Lal, Amos (2022-09-05)
      Coronavirus disease (COVID-19) can cause circulatory shock refractory to medical therapy. Such patients can be managed with mechanical circulatory support (MCS) devices like IABP, Impella, VA ECMO, and Left Ventricular Assist Devices (LVADs). Moreover, patients on long-term durable LVADs are a special population having increased susceptibility and mortality to COVID-19 infection. In this narrative review, we searched PubMed and Medline for studies on COVID-19 patients on short-term MCS devices. We found 36 papers with 110 patients who met our review criteria, including 89 LVAD patients and 21 COVID-19 patients who needed MCS device therapy. These studies were used to extract patient demographics, clinical presentation, MCS device details, management, and outcomes. Mean age of patients with COVID-19 infection on LVADs was 60, 73% were male, and HeartMate 3 was the most common device (53%). Most patients (77.5%) needed hospitalization, and mortality was 23.6%. Among the 21 reported cases of critically ill COVID-19 patients who required MCS, the mean age was 49.8 years, 52% were women, and the most common MCS device used was VA ECMO (62%) in conjunction with an Impella for LV venting. Comorbidities were not present in 43%, but 71% had abnormal ventricular function on echocardiography. MCS is a viable option for managing severe COVID-19 infection with shock, with many reported cases of favorable outcomes.
    • Endoscopic capsule robot-based diagnosis, navigation and localization in the gastrointestinal tract

      Hanscom, Mark; Cave, David R (2022-09-02)
      The proliferation of video capsule endoscopy (VCE) would not have been possible without continued technological improvements in imaging and locomotion. Advancements in imaging include both software and hardware improvements but perhaps the greatest software advancement in imaging comes in the form of artificial intelligence (AI). Current research into AI in VCE includes the diagnosis of tumors, gastrointestinal bleeding, Crohn's disease, and celiac disease. Other advancements have focused on the improvement of both camera technologies and alternative forms of imaging. Comparatively, advancements in locomotion have just started to approach clinical use and include onboard controlled locomotion, which involves miniaturizing a motor to incorporate into the video capsule, and externally controlled locomotion, which involves using an outside power source to maneuver the capsule itself. Advancements in locomotion hold promise to remove one of the major disadvantages of VCE, namely, its inability to obtain targeted diagnoses. Active capsule control could in turn unlock additional diagnostic and therapeutic potential, such as the ability to obtain targeted tissue biopsies or drug delivery. With both advancements in imaging and locomotion has come a corresponding need to be better able to process generated images and localize the capsule's position within the gastrointestinal tract. Technological advancements in computation performance have led to improvements in image compression and transfer, as well as advancements in sensor detection and alternative methods of capsule localization. Together, these advancements have led to the expansion of VCE across a number of indications, including the evaluation of esophageal and colon pathologies including esophagitis, esophageal varices, Crohn's disease, and polyps after incomplete colonoscopy. Current research has also suggested a role for VCE in acute gastrointestinal bleeding throughout the gastrointestinal tract, as well as in urgent settings such as the emergency department, and in resource-constrained settings, such as during the COVID-19 pandemic. VCE has solidified its role in the evaluation of small bowel bleeding and earned an important place in the practicing gastroenterologist's armamentarium. In the next few decades, further improvements in imaging and locomotion promise to open up even more clinical roles for the video capsule as a tool for non-invasive diagnosis of lumenal gastrointestinal pathologies.
    • Clinician perspectives on pediatric COVID-19 vaccination: A qualitative study in central and western, Massachusetts

      Ryan, Grace W; Goulding, Melissa; Borg, Amy; Minkah, Princilla; Hermann, Sophie; Fisher, Lloyd; Rosal, Milagros C.; Lemon, Stephenie C. (2022-09-01)
      We explored perspectives of clinicians in central and western Massachusetts about efforts to vaccinate pediatric patients against COVID-19 as well as best practices and challenges for vaccine delivery. We conducted semi-structured qualitative interviews (n = 16) with family practice and pediatric clinicians between late October and early December 2021. Our interviews addressed: process for vaccination and vaccine promotion, parental receptivity to COVID-19 vaccination, receptivity to other pediatric vaccines, resources needed to support vaccine promotion, and best practices developed to encourage hesitant parents. Using a multi-prong recruitment strategy we invited clinicians to participate in telephone interviews, which were audio-recorded and transcribed. We used rapid qualitative analysis to produce summary templates for each interview which were ultimately combined into a matrix summary. The majority of participants (n = 10) were offering the vaccine in their own clinics, while the remainder cited challenges related to staffing, logistics, and space that prevented them from offering the vaccine. Clinicians reported parents fall into three groups: vaccine-accepting, hesitant but potentially accepting, and refusers. Strategies they identified that worked to encourage hesitant parents were sharing personal vaccine stories, acknowledging parents' fears about the vaccine, and being persistent with the most hesitant parents. Yet resources are needed including educational materials and training in how to have these conversations. While challenges related to staffing and space will be difficult to overcome for clinics to be able to offer vaccination on-site, our results highlight the importance of developing effective messaging strategies and training clinicians in how to integrate them into routine practice.
    • Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans

      Iverson, Katherine M; Dardis, Christina M; Cowlishaw, Sean; Webermann, Aliya R; Shayani, Danielle R; Dichter, Melissa E; Mitchell, Karen S; Mattocks, Kristin M.; Gerber, Megan R; Portnoy, Galina R (2022-08-30)
      Background: Little is known about women veterans' intimate partner violence (IPV) experiences during the COVID-19 pandemic or the impacts of pandemic-related stress on their mental and physical health. Objectives: To identify IPV experiences among women veterans prior to and during the pandemic, pandemic-related stressors, and examine their respective contributions to mental and physical health. Design: National sample of women veterans drawn from a larger web-based longitudinal study. Relationships between recent IPV and pandemic-related stressors were tested with linear regressions, controlling for pre-pandemic IPV and mental and physical health symptoms, demographic, and military-related covariates. Participants: One hundred forty-two women veterans (Mage=58.8 years). Main measures: We assessed IPV (CTS-2), PTSD (PCL-5), depression (CESD), anxiety (DASS-A), physical health (PHQ-15), and physical health-related quality of life (SF-12) prior to the pandemic (June 2016-December 2016/January 2017) and during the pandemic study period (March 2020-December 2020/January 2021). We assessed pandemic-related stressors (EPII) during the pandemic study period. Key results: Over a third (38.7%) of participants experienced IPV during the pandemic study period (psychological: 35.9%, physical: 9.9%, sexual: 4.2%). Overall rates, frequency, and severity of IPV experience did not significantly differ between the pre-pandemic and pandemic study periods. Few participants tested positive for COVID-19 (4.2%); however, most participants reported experiencing pandemic-related stressors across life domains (e.g., social activities: 88%, physical health: 80.3%, emotional health: 68.3%). IPV during the pandemic and pandemic-related stressors were both associated with greater PTSD and depressive symptoms. Pandemic-related stressors were associated with worse anxiety and physical health symptoms. Neither IPV during the pandemic nor pandemic-related stressors were associated with physical health-related quality of life. Conclusions: IPV experiences during the pandemic were common among women veterans, as were pandemic-related stressors. Although IPV did not increase in the context of COVID-19, IPV experiences during the pandemic and pandemic-related stressors were linked with poorer mental and physical health.
    • Examining Pregnant Veterans' Acceptance and Beliefs Regarding the COVID-19 Vaccine

      Mattocks, Kristin M.; Kroll-Desrosiers, Aimee R.; Moore Simas, Tiffany A.; Bastian, Lori A; Marteeny, Valerie; Walker, Lorrie; Sheahan, Kate; Elwy, A Rani (2022-08-30)
      Background: Pregnant persons have received mixed messages regarding whether or not to receive COVID-19 vaccines as limited data are available regarding vaccine safety for pregnant and lactating persons and breastfeeding infants. Objective: The aims of this study were to examine pregnant Veteran's acceptance of COVID-19 vaccines, along with perceptions and beliefs regarding vaccine safety and vaccine conspiracy beliefs. Design and participants: We conducted a cross-sectional survey of pregnant Veterans enrolled in VA care who were taking part in an ongoing cohort study at 15 VA medical centers between January and May 2021. Main measures: Pregnant Veterans were asked whether they had been offered the COVID-19 vaccine during pregnancy, and whether they chose to accept or refuse it. Additional questions focused on perceptions of COVID-19 vaccine safety and endorsements of vaccine knowledge and conspiracy beliefs. Logistic regression was utilized to examine predictors of acceptance of a vaccine during pregnancy. Key results: Overall, 72 pregnant Veterans were offered a COVID-19 vaccine during pregnancy; over two-thirds (69%) opted not to receive a vaccine. Reasons for not receiving a vaccine included potential effects on the baby (64%), side effects for oneself (30%), and immunity from a past COVID-19 infection (12%). Those who received a vaccine had significantly greater vaccine knowledge and less belief in vaccine conspiracy theories. Greater knowledge of vaccines in general (aOR: 1.78; 95% CI: 1.2-2.6) and lower beliefs in vaccine conspiracies (aOR: 0.76; 95% CI: 0.6-0.9) were the strongest predictors of acceptance of a COVID-19 vaccine during pregnancy. Conclusions: Our study provides important insights regarding pregnant Veterans' decisions to accept the COVID-19 vaccine, and reasons why they may choose not to accept the vaccine. Given the high endorsement of vaccine conspiracy beliefs, trusted healthcare providers should have ongoing, open discussions about vaccine conspiracy beliefs and provide additional information to dispel these beliefs.
    • Lay Beliefs About Doctors' Knowledge of and Reasons for Recommending COVID-19 Vaccines

      Fisher, Kimberly A; Nguyen, Ngoc; Mazor, Kathleen M (2022-08-29)
      Commonly cited as the most trusted source of information about COVID-19 vaccines, healthcare providers have an important role in promoting COVID-19 vaccination While a healthcare provider recommendation is associated with greater likelihood of being vaccinated against COVID-193, there is limited understanding of lay beliefs about providers’ knowledge of COVID-19 vaccines and reasons for promoting vaccination.
    • Trends in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Seroprevalence in Massachusetts Estimated from Newborn Screening Specimens

      Ma, Kevin C; Hale, Jaime E; Grad, Yonatan H; Alter, Galit; Luzuriaga, Katherine; Eaton, Roger B; Fischinger, Stephanie; Kaur, Devinder; Brody, Robin; Siddiqui, Sameed M; et al. (2022-08-24)
      Background: Estimating the cumulative incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential for setting public health policies. We leveraged deidentified Massachusetts newborn screening specimens as an accessible, retrospective source of maternal antibodies for estimating statewide seroprevalence in a nontest-seeking population. Methods: We analyzed 72 117 newborn specimens collected from November 2019 through December 2020, representing 337 towns and cities across Massachusetts. Seroprevalence was estimated for the Massachusetts population after correcting for imperfect test specificity and nonrepresentative sampling using Bayesian multilevel regression and poststratification. Results: Statewide seroprevalence was estimated to be 0.03% (90% credible interval [CI], 0.00-0.11) in November 2019 and rose to 1.47% (90% CI: 1.00-2.13) by May 2020, following sustained SARS-CoV-2 transmission in the spring. Seroprevalence plateaued from May onward, reaching 2.15% (90% CI: 1.56-2.98) in December 2020. Seroprevalence varied substantially by community and was particularly associated with community percent non-Hispanic Black (β = .024; 90% CI: 0.004-0.044); i.e., a 10% increase in community percent non-Hispanic Black was associated with 27% higher odds of seropositivity. Seroprevalence estimates had good concordance with reported case counts and wastewater surveillance for most of 2020, prior to the resurgence of transmission in winter. Conclusions: Cumulative incidence of SARS-CoV-2 protective antibody in Massachusetts was low as of December 2020, indicating that a substantial fraction of the population was still susceptible. Maternal seroprevalence data from newborn screening can inform longitudinal trends and identify cities and towns at highest risk, particularly in settings where widespread diagnostic testing is unavailable.
    • Lack of Association between Pandemic School Mode Policy and Pediatric Body Mass Index Percentile over Time

      Fisher, Lloyd; Nelson, Richard E; Ertem, Zeynep; Schechter-Perkins, Elissa M; Oster, Emily; Branch-Elliman, Westyn (2022-08-24)
      During the 2020-2021 academic year, schools across the country were closed for prolonged periods. Prior research suggests that children tend to gain more weight during times of extended school closures, such as summer vacation; however, little is known about the impact of school learning mode on changes. Thus, the aim of this study was to measure the association between school mode (in-person, hybrid, remote) and pediatric body mass index (BMI) percentile increases over time. In this longitudinal, statewide retrospective cohort study in Massachusetts, we found that BMI percentile increased in elementary and middle school students in all learning modes, and that increases slowed but did not reverse following the statewide reopening. Body mass percentile increases were highest in elementary school aged children. Hispanic ethnicity and receipt of Medicaid insurance were also associated with increases. Additional research is needed to identify strategies to combat pediatric body mass percentile increases and to address disparities.
    • Patient-Reported Experiences of Breast Cancer Screening, Diagnosis, and Treatment Delay, and Telemedicine Adoption during COVID-19

      Du, Simo; Carfang, Laura; Restrepo, Emily; Benjamin, Christine; Epstein, Mara M; Fairley, Ricki; Roudebush, Laura; Hertz, Crystal; Eshraghi, Leah; Warner, Erica T (2022-08-20)
      Of 554 eligible survey participants, 493 provided complete data on demographic and socioeconomic factors and were included in the analysis. Approximately half (n = 248, 50.3%) had a personal history of breast cancer. Overall, 188 (38.1%) participants had experienced any COVID-19-related delay in care including screening, diagnosis, or treatment, and 339 (68.8) reported having at least one virtual appointment during the study period. Compared to other insurance types, participants with Medicaid insurance were 2.58 times more likely to report a COVID-19-related delay in care (OR 2.58, 95% Cl: 1.05, 6.32; p = 0.039). Compared to participants with a household income of less than USD 50,000, those with a household income of USD 150,000 or more were 2.38 (OR 2.38, 95% Cl: 1.09, 5.17; p = 0.029) times more likely to adopt virtual appointments. Self-insured participants were 70% less likely to use virtual appointment compared to those in other insurance categories (OR 0.28, 95% Cl: 0.11, 0.73; p = 0.009).
    • Early-stage COVID-19 pandemic observations on pulmonary embolism using nationwide multi-institutional data harvesting

      Wismüller, Axel; DSouza, Adora M; Abidin, Anas Z; Ali Vosoughi, M; Gange, Christopher; Cortopassi, Isabel O; Bozovic, Gracijela; Bankier, Alexander A; Batra, Kiran; Chodakiewitz, Yosef; et al. (2022-08-19)
      We introduce a multi-institutional data harvesting (MIDH) method for longitudinal observation of medical imaging utilization and reporting. By tracking both large-scale utilization and clinical imaging results data, the MIDH approach is targeted at measuring surrogates for important disease-related observational quantities over time. To quantitatively investigate its clinical applicability, we performed a retrospective multi-institutional study encompassing 13 healthcare systems throughout the United States before and after the 2020 COVID-19 pandemic. Using repurposed software infrastructure of a commercial AI-based image analysis service, we harvested data on medical imaging service requests and radiology reports for 40,037 computed tomography pulmonary angiograms (CTPA) to evaluate for pulmonary embolism (PE). Specifically, we compared two 70-day observational periods, namely (i) a pre-pandemic control period from 11/25/2019 through 2/2/2020, and (ii) a period during the early COVID-19 pandemic from 3/8/2020 through 5/16/2020. Natural language processing (NLP) on final radiology reports served as the ground truth for identifying positive PE cases, where we found an NLP accuracy of 98% for classifying radiology reports as positive or negative for PE based on a manual review of 2,400 radiology reports. Fewer CTPA exams were performed during the early COVID-19 pandemic than during the pre-pandemic period (9806 vs. 12,106). However, the PE positivity rate was significantly higher (11.6 vs. 9.9%, p < 10-4) with an excess of 92 PE cases during the early COVID-19 outbreak, i.e., ~1.3 daily PE cases more than statistically expected. Our results suggest that MIDH can contribute value as an exploratory tool, aiming at a better understanding of pandemic-related effects on healthcare.
    • Promotion of neutralizing antibody-independent immunity to wild-type and SARS-CoV-2 variants of concern using an RBD-Nucleocapsid fusion protein

      Castro, Julia T; Azevedo, Patrick; Fumagalli, Marcílio J; Hojo-Souza, Natalia S; Salazar, Natalia; Almeida, Gregório G; Oliveira, Livia I; Faustino, Lídia; Antonelli, Lis R; Marçal, Tomas G; et al. (2022-08-17)
      Both T cells and B cells have been shown to be generated after infection with SARS-CoV-2 yet protocols or experimental models to study one or the other are less common. Here, we generate a chimeric protein (SpiN) that comprises the receptor binding domain (RBD) from Spike (S) and the nucleocapsid (N) antigens from SARS-CoV-2. Memory CD4+ and CD8+ T cells specific for SpiN could be detected in the blood of both individuals vaccinated with Coronavac SARS-CoV-2 vaccine and COVID-19 convalescent donors. In mice, SpiN elicited a strong IFN-γ response by T cells and high levels of antibodies to the inactivated virus, but not detectable neutralizing antibodies (nAbs). Importantly, immunization of Syrian hamsters and the human Angiotensin Convertase Enzyme-2-transgenic (K18-ACE-2) mice with Poly ICLC-adjuvanted SpiN promotes robust resistance to the wild type SARS-CoV-2, as indicated by viral load, lung inflammation, clinical outcome and reduction of lethality. The protection induced by SpiN was ablated by depletion of CD4+ and CD8+ T cells and not transferred by antibodies from vaccinated mice. Finally, vaccination with SpiN also protects the K18-ACE-2 mice against infection with Delta and Omicron SARS-CoV-2 isolates. Hence, vaccine formulations that elicit effector T cells specific for the N and RBD proteins may be used to improve COVID-19 vaccines and potentially circumvent the immune escape by variants of concern.
    • Video and In-Person Palliative Care Delivery Challenges before and during the COVID-19 Pandemic

      Chua, Isaac S; Olmsted, Molly; Plotke, Rachel; Turk, Yael; Trotter, Chardria; Rinaldi, Simone; Kamdar, Mihir; Jackson, Vicki A; Gallagher-Medeiros, Emily R; El-Jawahri, Areej; et al. (2022-08-17)
      Context: Palliative care (PC) clinicians faced many challenges delivering outpatient care during the coronavirus-19 (COVID-19) pandemic. Objectives: We described trends for in-person and video visit PC delivery challenges before and during the COVID-19 pandemic in the U.S. Methods: We performed a secondary data analysis of patient characteristics and PC clinician surveys from a multisite randomized controlled trial at 20 academic cancer centers. Patients newly diagnosed with advanced lung cancer (N = 653) were randomly assigned to receive either early in-person or telehealth PC and had at least monthly PC clinician visits. PC clinicians completed surveys documenting PC delivery challenges after each encounter. We categorized patients into 3 subgroups according to their PC visit dates relative to the onset of the COVID-19 pandemic in the U.S.-pre-COVID-19 (all visits before March 1, 2020), pre/post-COVID-19 (≥1 visit before and after March 1, 2020), and post-COVID-19 (all visits after March 1, 2020). We performed Pearson's chi-squared, Fisher's exact, and Kruskal-Wallis tests to examine associations. Results: We analyzed 2329 surveys for video visits and 2176 surveys for in-person visits. For video visits, the pre-COVID-19 subgroup (25.8% [46/178]) had the most technical difficulties followed by the pre/post-COVID-19 subgroup (17.2% [307/1784]) and then the post-COVID-19 subgroup (11.4% [42/367]) (P = 0.0001). For in-person visits, challenges related to absent patients' family members occurred most often in the post-COVID-19 subgroup (6.2% [16/259]) followed by the pre/post-COVID-19 subgroup (3.6% [50/1374]) and then the pre-COVID-19 subgroup (2.2% [12/543]) (P = 0.02). Conclusion: Technical difficulties related to PC video visits improved, whereas in-person visit challenges related to absent patients' family members worsened during the pandemic.
    • Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home prospective cohort study [preprint]

      Soni, Apurv; Herbert, Carly; Lin, Honghuang; Pretz, Caitlin; Stamegna, Pamela; Orwig, Taylor; Wright, Colton; Tarrant, Seanan; Behar, Stephanie; Suvarna, Thejas; et al. (2022-08-06)
      Background: Performance of Rapid Antigen Tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance is not well established among asymptomatic individuals. Objective: Evaluate performance of Ag-RDT for detection of SARS-CoV-2 in relation to onset of infection for symptomatic and asymptomatic participants. Design setting and participants: Prospective cohort study conducted from October 2021 to February 2022 among participants > 2 years-old from across the US who enrolled using a smartphone app. During each testing encounter, participants self-collected one nasal swab and performed Ag-RDT at home; at-least fifteen minutes later, a second nasal swab was self-collected and shipped for SARS-CoV-2 RT-PCR at a central lab. Both nasal swabs were collected 7 times at 48-hour intervals (over approximately 14 days) followed by an extra nasal swab collection with home Ag-RDT test 48-hours after their last PCR sample. Each participant was assigned to one of the three emergency use authorized (EUA) Ag-RDT tests used in this study. This analysis was limited to participants who were asymptomatic and tested negative by antigen and molecular test on their first day of study participation. Exposure: SARS-CoV-2 positivity was determined by testing a single home-collected anterior nasal sample with three FDA EUA molecular tests, where 2 out 3 positive test results were needed to determine a SARS-CoV-2 positive result. Onset of infection was defined as day on which the molecular PCR comparator result was positive for the first time. Main outcomes and measures: Sensitivity of Ag-RDT was measured based on testing once (same-day), twice (at 48-hours) and thrice (at 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status on a given DPIPP. Results: A total of 7,361 participants enrolled in the study and 5,609 were eligible for this analysis. Among 154 eligible participants who tested positive for SARS-CoV-2 infection based on RT-PCR, 97 were asymptomatic and 57 had symptoms at onset of infection (DPIPP 0). Serial testing with Ag-RDT twice over 48-hours resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Among the 97 people who were asymptomatic at the onset of infection, 19 were singleton RT-PCR positive, i.e., their positive test was preceded and followed by a negative RT-PCR test within 48-hours. Excluding these singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with serial testing three times at 48-hour interval. Discussion: Performance of Ag-RDT within first week of infection was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.
    • Finding a Needle in the Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection [preprint]

      Soni, Apurv; Herbert, Carly; Pretz, Caitlin; Stamegna, Pamela; Filippaios, Andreas; Shi, Qiming; Suvarna, Thejas; Harman, Emma; Schrader, Summer; Nowak, Chris; et al. (2022-08-05)
      Background: Over-the-counter rapid antigen tests for SARS-CoV-2 with an Emergency Use Authorization (EUA) in the United States generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. A goal of this study was to investigate the performance of SARS-CoV-2 antigen serial testing and generate data to support regulatory decisions. Objective: To describe a novel study design to evaluate serial use of rapid antigen tests in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Eligible participants from across the U.S. could enroll and complete this study from their home environment through a study app. Participant enrollment was prioritized based on regional 7-day case rates, participants' vaccination status, and sociodemographic characteristics prior to enrollment.Prioritization criteria were adjusted on a daily or weekly basis. Enrolled participants were mailed rapid antigen tests and molecular comparator collection kits and asked to test every 48 hours for 15 days. Three companies' rapid antigen tests were used in the study; assignment of participant to a test was criteria-based and non-random, precluding head-to-head comparison between the tests. Participants: Mainland United States residents over 2 years old with no reported COVID-19 symptoms in the 14 days prior to study enrollment. Main measures: Participant demographics, COVID-19 vaccination status, and geographic distribution were used to understand the impact of the site-less recruitment and enrollment strategy. Key results: A total of 7,361 participants enrolled in the study between October 18, 2021 and February 15, 2022. Throughout the study, 369 participants tested positive for SARS-CoV-2, including 167 who were asymptomatic and tested negative on SARS-CoV-2 molecular assays to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 of the 48 mainland U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The novel, digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.